1. Introduction to the Institutional Review Board
CassiDe Street, Ph.D.
Section Manager, HRPP

2. Institutional Review Board
Mission
Institutional Review Board
To protect the rights and welfare of human subjects involved in research at Texas Tech University
Committee
Must be highly diverse
One non-scientific member
One non-affiliated member
One prisoner representative
Faculty members from TTU

3. Human Research Protection Program
Mission
Human Research Protection Program
Maintains all IRB records including meeting agendas and minutes, policies, regulations, forms, reference materials, and protocols
Educate investigators and public on human research
Serves as the point of contact for IRB
Responds to non-compliance reports

4. Events that Lead to the Need for an IRB
World War II
Tuskegee Syphilis Study (1932 – 1972)
N = 600 black men, 399 with syphilis
Thought they were being treated for “bad blood”
Study lasted 40 years and not offered penicillin
Zimbardo (1971)
Stanford prison study
N = 24, clinically sane individual were randomly assigned to be prisoners or guards
Study was suppose to last 2 weeks only lasted 6 days

5. Three Basic Ethical Principles
The Belmont Report (1976)
Three Basic Ethical Principles
Respect for Persons
Voluntary informed consent
Respect for privacy
Added protections (children, prisoners, pregnant women/fetuses)
Beneficence “do no harm”
Maximize benefits, minimize risks
Risk: physical, psychological, social, economic, legal
No greater than your normal daily life

6. The Belmont Report: Three Basic Ethical Principles
Justice
Equitable selection of subjects, inclusion and exclusion criteria
Coercion
Excessive or inappropriate reward
Subjects are reimbursed for their time; not paid for their participation
Equal distribution of both benefits and burdens of research

7. 45 Code of Federal Regulations, Part 46 (45 CFR 46)
The Common Rule
Research
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge
Human Subjects
a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) data through intervention or interaction with the individual
(2) identifiable private information

8. 45 Code of Federal Regulations, Part 46 (45 CFR 46)
The Common Rule
Intervention
Manipulations of the environment
Interaction with human subject(s)
Individual can reasonably expect their actions will not be made public

9. International Research

10. International Approval
Approval Process
Texas Tech University IRB
Texas Tech is the lead institution
Approval secured here first.
Reliance agreements for collaborators outside of Texas Tech
Lead Institution’s IRB/Ethical Approval
Texas Tech is a collaborator and not the lead institution
Reliance agreement will be established
Country Approval to Conduct Research
Different for every country

11. Permission to Conduct Research
Community
Elders
Tribal Leader
Government Officials/Councils
Organizations
Companies
Schools

12. Elements of Consent Purpose of Research Clear and Concise
Consent Process
Elements of Consent
Purpose of Research
Participant Activities
Time involved
Benefits and Risks
Clear and Concise
IRB requires consent document in English and Foreign Language
Appropriate reading level for the target population
Or appropriate consent process for age group

13. Cont. Volunteer Privacy
Consent Process
Cont.
Volunteer
Not forced or coerced to participate in research
Can quit at anytime without penalty
Privacy
Only researchers will know who participated in the study
Remove identifiers from data
Investigator Contact Information
HRPP Contact Information

14. Respect for the laws and regulations Aware of their cultural norms
Age of minors v. adults
Sensitive topics
Appropriate person to conduct research
Permission
Recruitment
Consent
Data Collection

15. Data was collected ethically
Secondary Analysis
Data was collected ethically
IRB/Ethics approval
Letter
Protocol
Consent Process/Document
Do the participants know their data is being shared for future studies?
Be aware of data that was:
Illegally obtained
Hacked
Unethically collected
Not voluntarily
Coerced into participation
Risks

16. Environmental Health & Safety
TTU Resources
Export Control
Contact TTU Export Control at or  TTU OP 74.10
Environmental Health & Safety
Biospecimens stored on Texas Tech campus
International Cultural Center

17. Review Types

18. Levels of Review
Exempt Review
Involves minimal risk and fits certain precisely defined categories
Typically anonymous data
Exemptions cannot be granted for:
Projects with children as subjects that involve interview or survey procedures
Research where public behavior is observed and the investigator participates or interacts

19. Exempt Review Established or commonly accepted educational settings
Levels of Review
Exempt Review
Established or commonly accepted educational settings
Regular and special educational instruction strategies
Effectiveness of instructional techniques, curricula or classroom management
Educational test, survey or interview procedures, or observations of public behavior
Cannot be identified directly or through identifiers linked to the subjects
Subjects responses could not place the subject at risk
Elected officials or candidates for public office

20. Levels of Review
Exempt Review
Existing data, documents, records, pathological or diagnostic specimens under specific conditions
Available to the public
Subjects cannot be identified
Taste and food quality evaluation
Wholesome foods without additives are consumed
Another provision of 45 CFR (2)

21. Expedited Review Involves no more than minimal risk
Levels of Review
Expedited Review
Involves no more than minimal risk
May include identifiers and data that needs to be protected and kept confidential
Children

22. Expedited Review Clinical studies of drugs and medical devices
Levels of Review
Expedited Review
Clinical studies of drugs and medical devices
Blood samples
Biological specimens
Noninvasive procedures
Research involving materials that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis)

23. ( NOTE: Some research in this category may be exempt.)
Levels of Review
Expedited Review
Data from voice, video, digital, or image recordings
Individual or group characteristics or behavior
Employing survey
Interview
Oral history
Focus group
Human factors evaluation
Quality assurance
( NOTE: Some research in this category may be exempt.)

24. Full Board Review Last Tuesday of the Month
Levels of Review
Full Board Review
Last Tuesday of the Month
Involves a higher degree of potential risk to human subjects
Genetics (identifiable information, future use)
Medical procedures
Vulnerable populations
Prisoners
Exercise and sports activity
Pregnant Women/fetuses

25. HRPP OFFICE
Administration 357